Legislation

ALL LEGISLATION
10.3.1. List of names for substances for pharmaceutical use and preparations presented in European Pharmacopoeia
10.3.3 The lists of Standard Terms for Pharmaceutical dose forms and Patient-friendly terms, for Combined pharmaceutical dose forms terms, for Combined terms, for Containers, closures and administration devices terms, for Routes and methods of administration terms, for Combination packs terms and for Units of presentation terms.
Commission Regulation (EC)No 1084/2003
Commission Regulation (EC)No 1084/2003
Good manufactures practice requirements
Composition of names of medicinal products
Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
Application form for change in classification to a marketing authorisation
1.1 Law of pharmacy
2.1.1. Rules for granting marketing authorization for medicinal products
5.1. The Law on Ethics of Biomedical Research
4.4 SMCA requirements for Post-Authorisation Safety Studies (only in Lithuanian)
4.1. ADR reporting rules for health care profesionals, pharmacists and patients (only in Lithuanian)
11.1. The rules of reporting about sales of medicinal products packages and remainders of medicinal products packages in the Republic of Lithuania (only in Lithuanian)
6.1. Law on advertising
7.5.2. On the Approval of the Regulations of Issuing Licences (only in Lithuanian)
6.2. Law on competition
2.3.4. Regarding sale out of packages of medicinal products
4.6. Regarding Pharmacovigilance Inspections (only in Lithuanian)
3.2. Rules on supply to the market of unauthorized medicinal products of the necessary assortment (only in Lithuanian)
3.1. Rules on obtaining of nominal medicinal products prescribed for individual patient (only in Lithuanian)
6.4. Rules on the advertising of medicines (only in Lithuanian)
7.2.1 Law on the Control of Narcotic and Psychotropic Substances
6.3. Law on Provision of Information to the Public
7.3.1. Schedule of Narcotic drugs and pshychotropic substances (only in Lithuanian)
10. The list of Recommended International NonProprietary Names for pharmaceutical substances (INN) in English, Lithuanian and Latin languages
5.13. Order No.1A-72 of 26 Jan 2011 of the Director of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania “Regarding confirmation of rules of inspections regarding conduct of clinical trials of medicinal products, confirmation of forms inspection protocol regarding conduct of clinical trials of medicinal products and confirmation of forms of register of protocols regarding conduct of clinical trials of medicinal products”
2.2.5. Common Baltic Package Guidance
5.11. Order No 1A-91 of 18 Jan 2007 of the Director of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania “Regarding confirmation of the description of the requirements applied for preparation of good clinical practice training and composition of programs”

5.5. Order No. 1A-663 of 30 Oct 2006 of the Director of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania “Regarding confirmation of the description of the order applied for reporting about undesirable events observed during clinical trials of medicinal products and undesirable reactions to investigated medicinal products”

5.4. Order No. 1A-396 of 26 Jul 2006 of the Director of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania “Regarding the order applied for application to obtain permission to conduct clinical trial of human medicinal products, reporting about essential amendments and submission of declaration about ending of the trial”
Resolution No 1194 on the Amendment of the Resolution No 802 on the approval of pharmaceuticals activities licensing rules
Commission Directive 2003/94/EC, of 8 October 2003
Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004
Volume 4 - Good Manufacturing Practices
Revised compilation of community procedures on administrative collaboration and harmonisation of inspections
Order No V-735 on Verification of activity of pharmaceutical enterprises regarding compliance to the requirements of good manufacturing practice and good distribution practice of medicines
Order No 320 on Rules of good distribution practice of medicines
Order No V-268 on Regulations of good manufacturing practice of medicinal products and investigative medicines
Order No 112 on Writing medicinal prescriptions and release (sale) of medicines
Order No V-7 on Requirements for pharmacies
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
Directive 2001/20/EC OF the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the impl
Commission Directive 91/356/EEC, of 13 June 1991, laying down the principles and guidelines of good manufacturing practice for medicinal products for human use
Council Directive 89/105/EEC, of 21 December 1988, relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national
Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice
Commission Directive 2003/94/EC, of 8 October 2003
Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004
Volume 4 - Good Manufacturing Practices
Law on pharmaceuticals activities
5.2. Order of the Ministry of Health No V-435 of May 31 2006 „Regarding confirmation of the description of the order on approval to conduct clinical trial of medicinal product, issuance of certificates and permissions to conduct clinical trial of medicinal product, order of performance and control of trials“
Law on the Control of Narcotic and Psychotropic Substances
12. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Consolided version : 05/10/2009).
5.3. Order No. 1A-205 of 19April 2005 of the Director of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania Regarding amendment of the Order No 70 of the Director of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania of 18 June 2002 „Regarding requirements applied for clinical trials with participation of children“
9.1.2 Law on the Ratification of the Convention on the Elaboration of a European Pharmacopoeia, Amended According to the Provision of the Protocol to the Convention on the Elaboration of a European Pharmacopoeia
10.1.1 Convention on the Elaboration of a European Pharmacopoeia

 

 

Last updated: 28-11-2023